MAUDE manufacturer profile
SUNMED HOLDINGS LLC · BTL
MAUDE profile for Ventilator, Emergency, Powered (Resuscitator)
Key facts
| Manufacturer | SUNMED HOLDINGS LLC |
|---|---|
| Manufacturer group | SUNMED HOLIDNGS LLC |
| Product code | BTL |
| Product code name | Ventilator, Emergency, Powered (Resuscitator) |
At a glance
- 1–9 MAUDE reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Pressure, Output below Specifications, Pressure Problem, No Clinical Signs, Symptoms or Conditions Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1